Roux-en-Y gastric bypass
Conditions
Interventions
Trade Name: Metoprolol tartraat 100 mg tablet
Pharmaceutical Form: Tablet
Sponsors
Medisch Centrum Leeuwarden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ten female bariatric surgery patient volunteers will participate in this study. Inclusion criteria - Female gender - Age 18-50 years - Scheduled for Roux-en-Y gastric bypass surgery - Good liver and kidney function - Normal ECG - Intermediate or extensive CYP 2D6 metabolizer, evidenced by genotyping. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria - Pregnancy - Smoking - Alcohol: more than 7 drinks a week or 4 or more drinks during a single occasion - Use of alcohol during the period 24 hours before until 48 hours after the start of each phase of the study - Use of metoprolol - The use of CYP 2D6 inhibiting, inducing or metabolising drugs - The use of drugs that may interact with metoprolol o Calcium antagonist o Lidocaine o Digoxin - Use of a proton pump inhibitor - Use of laxatives - An existing contraindication for the use of metoprolol o Sick-sinus syndrome o Second and third degree heart block o Systolic blood pressure less than 100 mmHg o Cardiogenic shock o Sinus bradycardia o Cardiac failure, overt o Cardiac failure, moderate to severe o Untreated pheochromocytoma o Heart rate less than 45 beats/minute o First degree heart block (P-R interval 0.24 sec or greater) o Severe bronchial asthma or a history of severe bronchospasm o Hypersensitivity to metoprolol, related derivatives, other beta-blockers, or any component of the product o Severe peripheral arterial circulatory disorders - Previous surgery of the upper gastrointestinal tract - Disease or any other condition that may interfere with gastrointestinal absorption - Suffering from dumping syndrome after RYGB surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of Roux-en-Y gastric bypass on the rate and extent of absorption of metoprolol and its main active metabolite a-OH metoprolol after a single oral dose of 100 mg of metoprolol IR tablet in 10 female bariatric surgery patient volunteers, before and after surgery. The pharmacokinetic parameters that will be determined are: - Cmax The maximum serum concentration of metoprolol. - Tmax The time after oral administration of metoprolol when the maximum serum concentration is reached. - AUC t=0-10 The area under the serum concentration-time curve, a measurement of the bioavailability of metoprolol until 10 hours after intake. The effect can be determined according to the ratios as listed in the study protocol. ;Secondary Objective: not applicable;Primary end point(s): Parameters that will be determined before and after surgery are Cmax, Tmax, and AUC0-10 of metoprolol and its main active metabolite a-OH metoprolol. The main endpoint is the ratio of AUCafter/AUCbefore of metoprolol and a-OH metoprolol.;Timepoint(s) of evaluation of this end point: After last visit of last subject. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoint is the quotient of the ratios of the AUC of metoprolol and its metabolite after and before. Other study parameters Blood pressure and heart rate measured at t = 0, 2, 4, 8 and 10 hours after intake of metoprolol. Further analysis After completion of the other pharmacokinetic study with metoprolol controlled release tablet relevant parameters may be compared for further analysis.;Timepoint(s) of evaluation of this end point: After last visit of last subject. | — |
Countries
Netherlands
Contacts
Public ContactMCL Academie
Medisch Centrum Leeuwarden
Outcome results
None listed